BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325

    K Number: K001827 · Decision Aug 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    9
    Review Days
    63

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    Basic Information

    Device Name
    PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
    K Number
    K001827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Minimed, Inc.
    Date Received
    June 16, 2000
    Decision Date
    August 18, 2000
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPA Set, Administration, Intravascular

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    K021974 MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
    K010377 MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
    K001829 MINIMED PARADIGM INSULIN PUMP, MODEL 511
    K001832 PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318
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